Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CIPROXR · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Ciprofloxacin | EXPERIMENTAL | Ciprofloxacin Extended Release Tablets of Dr. Reddy's Laboratories Limited |
| CIPRO®XR | ACTIVE_COMPARATOR | CIPRO® XR (Bayer Health Care, Bayer Pharmaceuticals Corporation) Tablets |
| Name | Type | Description |
|---|---|---|
| CIPRO®XR | DRUG | Ciprofloxacin 1000 mg Tablets Dr. Reddy's Laboratories Limited |
Inclusion Criteria: 1. Non-institutionalized subjects consisting of members of, the coInmunity at large. 2. All subjects selected for this study will be non-smokers between 18 and 45 years of age (inclusive). Female subjects must be unable to become pregnant (postmenopausal for at least 1 year, or ...
CIPROXR is an investigational small molecule being studied for use in fed and fasting conditions. It is a ciprofloxacin 1000 mg extended-release tablet formulation developed by Dr. Reddy's Laboratories Ltd. The drug is currently in Phase 1 clinical development, with studies conducted in healthy volunteers in the United States.
CIPROXR is a small molecule drug that contains ciprofloxacin, a fluoroquinolone antibiotic. It is being studied as an extended-release tablet formulation. The drug targets bacterial DNA gyrase and topoisomerase IV, which are essential for bacterial DNA replication, though this mechanism is not explicitly stated in the clinical trial data.
CIPROXR is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting Phase 1 clinical trials to evaluate the bioavailability of this ciprofloxacin 1000 mg extended-release tablet formulation in healthy volunteers.
CIPROXR is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trials are designed to assess the bioavailability of the drug under fasting and fed conditions, and both studies have been completed.
CIPROXR has been studied in two completed Phase 1 clinical trials. The first, NCT01372345, evaluated the bioavailability of ciprofloxacin 1000 mg ER tablets under fasting conditions with 43 participants. The second, NCT01372358, assessed the same formulation under non-fasting (fed) conditions with 32 participants. Both trials were conducted in the United States.
CIPROXR is a branded formulation of ciprofloxacin, specifically a 1000 mg extended-release tablet. It is being developed by Dr. Reddy's Laboratories to provide an alternative to existing ciprofloxacin products. The clinical trials focus on its bioavailability under fasting and fed conditions, indicating it is a generic or bioequivalent version of the antibiotic.